Objective: To review the methodological insights gained from the CLASS and VIGOR coxib trials and make suggestions for primary safety outcomes in future trials.
Study Design And Setting: We reviewed the methodology and findings of recent coxib trials and similar studies that have produced considerable controversy.
Results: There were statistical power problems with the primary and unexpected endpoints in both coxib trials. One approach for decreasing sample size requirements is using composite outcomes, wherein different clinically relevant endpoints are combined. By virtue of increasing the event rate fewer patients are required to detect a relative treatment effect of 50%.
Conclusions: The recent withdrawal from the market of rofecoxib took years; the approach proposed here could shorten this time. It is important to revisit the comprehensiveness of the ability to detect important outcomes. Composite outcomes can be more varied in content, including mortality and morbidity. The proposed basket would consist of predefined designated endpoints in each organ system that could be associated with the population one is treating, and not just expected to be related to treatment. The goal is to anticipate and have a reasonable chance of detecting the unexpected side effect.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.jclinepi.2004.11.028 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Efficacy of preemptive multimodal analgesia initiated at various time points before total knee arthroplasty: a prospective, double-blind randomized controlled trial.
Arch Orthop Trauma Surg
December 2024
Department of Orthopedic Surgery, West China Hospital, Sichuan University, 37# Wainan Guoxue Road, Chengdu, Sichuan, 610041, People's Republic of China.
Introduction: Preemptive multimodal analgesia (PMA) is commonly employed for pain control after total knee arthroplasty (TKA). However, the optimal timing for initiating PMA remains unclear. This study aimed to compare the efficacy of PMA administered at different time points before TKA.
View Article and Find Full Text PDFEfficacy and safety of 4-hydroxy 2-methyl-N-(5-methyl-2-thiazolyl)-2H-1, 2-benzothiazin-3-carboxamide 1,1-dioxide, a fast-acting meloxicam formulation, on moderate-to-severe pain following abdominal surgery: A phase III randomized controlled trial.
Clin Transl Sci
December 2024
Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Article Synopsis
- A study evaluated a new long-lasting pain relief medication called QP001, compared to a placebo, to determine its effectiveness and safety for patients after abdominal surgery.
- Conducted across 23 centers, 255 patients were administered either QP001 or placebo, and the results showed QP001 significantly reduced pain intensity for up to 24 hours post-surgery.
- The trial indicated that QP001 also reduced the need for morphine and increased patient satisfaction, with no significant difference in adverse events compared to placebo.
Expert consensus recommendations for the diagnosis and treatment of chronic non-bacterial osteitis (CNO) in adults.
Ann Rheum Dis
November 2024
Center for Bone Quality, Leiden University Medical Center, Leiden, The Netherlands.
Background: There is considerable practice variation in labelling, diagnosis and treatment of adults with sterile bone inflammation. We developed a expert consensus recommendations on the disease definition, diagnosis and treatment of this rare condition.
Methods: Systematic literature review and Grading of Recommendations, Assessment, Development and Evaluations-based appraisal of evidence, two Delphi surveys and three digital and in-person consensus meetings with a multidisciplinary expert panel and patient representatives.
Impact of transdermal buprenorphine patch combined with celecoxib on improving shoulder pain and function of patients with primary adhesive shoulder capsulitis.
BMC Musculoskelet Disord
November 2024
Department of Pain, The Third People's Hospital of Hubei Province, Jianghan University, No. 26 Zhongshan Avenue, Wuhan, Hubei, 430022, China.
Background: One of the main purposes of clinical treatment for adhesive shoulder capsulitis is pain relief. However, patients often fail to achieve a satisfactory therapeutic response. This study aims to evaluate the impact of a combination therapy involving buprenorphine transdermal patch and celecoxib capsules on improving shoulder pain and function of patients with primary adhesive shoulder capsulitis (ASC).
View Article and Find Full Text PDFComparison of a fixed-dose combination of Celecoxib/PG201 [Layla®] versus co-administration of individual formulations in healthy participants: A randomized trial.
Medicine (Baltimore)
November 2024
Clinical Trials Center, Chungnam National University Hospital, Daejeon, Republic of Korea.
Article Synopsis
- Osteoarthritis (OA) is a common joint disease with no definitive treatment options, leading to the investigation of a new combination drug, PK101, which includes a herbal extract and celecoxib.
- A clinical study was conducted with healthy participants using a crossover design to compare the pharmacokinetics and safety of PK101 against its individual components.
- Results showed that PK101 had comparable absorption and concentration levels of celecoxib as the individual formulations, with some mild adverse events reported, indicating potential for further exploration in OA treatment.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!